Home » FDA, Industry Inch Closer Toward MDUFA Agreements
FDA, Industry Inch Closer Toward MDUFA Agreements
The FDA’s recent MDUFA counter-proposal suggests a slowly closing gap between the agency and industry negotiations.
Updated meeting minutes from May 16, present the agency’s counter-proposal, which presented two options with different levels of performance targets and associated resources needs, with an estimated $30 million difference between the two options.
FDA’s proposal included a base of $680 million plus inflation that would be raised by user fees based on current MUDFA III levels.
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